OHSRP AND THE NIH INTRAMURAL IRB JONATHAN M GREEN, MD MBA DIRECTOR: OFFICE OF HUMAN SUBJECTS RESEARCH PROTECTIONS
OHSRP AND THE NIH INTRAMURAL IRBJONATHAN M GREEN, MD MBA
DIRECTOR: OFFICE OF HUMAN SUBJECTS RESEARCH PROTECTIONS
Who I amClinician
Researcher
IRB professional
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• To protect the rights, welfare and safety of human subjects participating in research conducted by the NIH Intramural Research Program.
• To promote the ethical conduct of human subjects research by collaborating with investigators throughout the research lifecycle.
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HRPPs are a PartnershipInvestigators
Institution
Sponsors
IRBs
Participants
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Build upon the existing strengths of the NIH IRP to create a human research protection program that fosters research by providing:• Optimal participant protections• Efficiency and consistency• Regulatory compliance• Educational outreach
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Complex Regulatory EnvironmentCommon Rule (pre-2018 and 2018)
FDA regulations
DoD regulations
Privacy Act
HIPAA
NIH policy
ICH-GCP
Single IRB mandate
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Back to the future
27 ICs12 IRBs12 administrative offices12 different processesOversight by IC leadership
InefficiencyInconsistencyVariable QualityIC control
1 IRB1 Central administrative office1 way of doing thingsIndependence
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StepsRevise HRPP policies -- Stand up centralized administrative office
Reorganize IRBs under OD
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Policy RevisionsSimplify
Keep focus on policy not operations
Compliance with revised Common Rule
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OHSRPPre-9/2018
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Office of IRB Operations
Office of Policy Office of ComplianceAnd Training
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Office of IRB Operations (IRBO)Director: Tiffany Gommel
Functions• Exempt/NHSR determinations• Expedited Review• Administrative screening and support for Full Board
Review• NIH iRIS system• Coordinate sIRB activity• Investigator support• IRB member support
Website: irbo.nih.gov
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http://irbo.nih.gov/
Office of PolicyManager: Heather Bridge
Continual evaluation and development of policy Functionality Compliance Address new regulatory and ethical challenges
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Office of Compliance and Training
Manager: Peg Sanders
Triage reportable events
Manage non-compliance investigations
Support Research Compliance Review Committee
Create and implement educational programs for investigators and IRB members
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IRB Restructuring
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System inefficiencies and bottlenecks
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System inefficiencies and bottlenecks
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Committee reorganization
IRB 1 IRB 2 IRB 3 IRB 4 IRB 5
IRB 7 IRB 11IRB 8 IRB 9 IRB 10
IRB 6
IRB 12
15-20 members/committeeMeet monthly for 2-6 hours??? agenda items
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Penguins and Platypuses
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Flexible IRBCommittee makeup 9 primary members remainder alternates
3 PS4 OS2 NS
Physician Scientists
Non-physician Scientists
Non-Scientists
6 meetings per week~ 1 hour per meeting6-8 agenda items (1 IR)
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Screening Scheduling
M1
M2
M3
M4
M1
M2
M3
M4
Week 1 Week 2
IRB member
M1
M2
M3
M4
M1
M2
M3
M4
Week 3 Week 4
PS OS NS
IRB meetings
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IRB Chairs
Executive Chair: Nicole Grant
• Regulatory authority for approval• Provides leadership to FB committee chairs• Delegates authority to expedited review staff• Provides consultation as needed to expedited
review staff
Team of FB chairs
• Provide overall leadership to FB• Lead one meeting per week (in general)• Work together to achieve consistency across
meetings
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Benefits
Increased efficiency Maximal flexibility in scheduling = minimal time in the holding pen Capacity can be easily matched to demand
Improved reviews Dynamic committee membership = diverse and fresh perspectives Dedicated chairs committed to the process provide consistency
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Research Compliance Review Committee
Duly convened IRB
Stable membership• Experienced clinical
researchers• Experienced IRB
members
Review potential serious/continuing
non-compliance for all protocols
Focus on identifying
systemic problems and developing
solutions
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Progress to date…….
IRBO~50% hired (not onboarded)Supporting new NIH IM IRB
NIH Intramural IRBRegistered with OHSRP 12/2018
Reviewing all new protocols since January 21, 2019
Rolling in IC IRBs beginning 7/1/2019
Compliance and trainingManager and 1 staff
Revised relevant policiesHiring in progressRCRC established
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Where are we headed…..
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Whats left?Build capacity of IRBO
Assimilate existing IRBs
Optimize iRIS
Finish policy updates
sIRB processes
Office of Compliance and Training
Optimize processes for investigators
Communicate, communicate, communicate
Everything else…..
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NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.
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OHSRP AND THE NIH INTRAMURAL IRBWho I amOur MissionHRPPs are a PartnershipGoalComplex Regulatory EnvironmentBack to the futureStepsPolicy RevisionsOHSRP pre-9/2018Office of IRB Operations, Office of Policy, Office of Compliance and TrainingOffice of IRB Operations (IRBO)Office of PolicyOffice of Compliance and TrainingIRB RestructuringSystem inefficiencies and bottlenecksSystem inefficiencies and bottlenecksCommittee reorganizationPenguins and Platypuses Flexible IRBScreening, Scheduling, IRB meetingsIRB ChairsBenefitsResearch Compliance Review CommitteeProgress to date…….Where are we headed…..Whats left?NIH's MissionQuestions?